759 Multivariate Analysis and Reduced Variability in Support of Development or Manufacture of Medicines

Monday, November 9, 2015: 12:30 PM - 3:00 PM
Ballroom D (Salt Palace Convention Center)

This session is focused on the advances in the application of multivariate statistical approaches (both latent variable and other approaches) to support the development and manufacture of medicine through the reduction of variability or deviation; i.e. increasing process robustness. These approaches can include data visualization, statistical process control algorithms, chemometrics, and chemical or biochemical process modeling for drug product and drug substance applications. Contributions for both industry and academia are encouraged.

Pharmaceutical Discovery, Development and Manufacturing Forum
Pharmaceuticals (15B)
Dominique Hebrault Email: Dominique.Hebrault@mt.com
Jacob Albrecht Email: jacob.albrecht@bms.com

12:30 PM
(759a) A Case Study of Data Analytics for the Manufacturing of a Monoclonal Antibody
Kristen Severson, Jeremy G. VanAntwerp, Venkatesh Natarajan, Chris Antoniou, Jörg Thömmes and Richard D. Braatz

12:47 PM
(759b) Application of a Closed-Loop Analysis Approach to Achieve Process Robustness of a 25,000L Mammalian Cell Culture Process
Simpson Gregoire, Joseph Shiminsky, Cheng Wenren, Daniel Maskas, Danielle Harrison, Eric Garr and Jeffrey Savard

1:04 PM
(759c) Clone and Media Selection in Mab Biosimilar Process Development
Michael Sokolov, Jonathan Ritscher, Miroslav Soos, Nicola MacKinnon, Arnaud Perilleux, Matthieu Stettler, Hervé Broly, Massimo Morbidelli and Alessandro Butté

1:21 PM
(759d) Efficient Experiment Design and Model Generation to Assist Process Decision Making
Brendan C. Mack, Benjamin Cohen, Richard Fox, Scott Jones and David A. Conlon

2:12 PM
(759g) Improving Yield of Drug Product Manufacturing with Hybrid Approach
Lukas Eberle, Hirokazu Sugiyama, Stavros Papadokonstantakis, Andreas Graser, Rainer Schmidt and Konrad Hungerbuehler